FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices. The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March […]
Accenture to buy Irish manufacturing services company
Accenture (NYSE:ACN) has agreed to acquire Enterprise System Partners (ESP), a consulting and manufacturing services provider for the life sciences industry. Headquartered in Cork, Ireland, ESP will join Accenture’s digital manufacturing arm, Industry X.0, to boost Accenture’s efforts to transform manufacturing for pharmaceutical, biotech and medical device clients globally. Get the full story on our sister site, Medical […]
Medical device tax repeal bill reintroduced in U.S. Senate
U.S. Senator and Democratic presidential candidate Amy Klobuchar (D-Minn.) reintroduced a bill to permanently repeal the 2.3% federal excise tax on medical device sales, with a new co-sponsor. Sen. Pat Toomey (R-Penn.) has signed on to co-sponsor, replacing Sen. Orrin Hatch (R-Utah), who did not run for re-election last fall. The medical device tax went […]
Omni sold to U.K. ortho company Corin Group
U.K. international orthopedic company Corin Group said it will acquire Omni, a robotic knee surgery platform developer. Raynham, Mass.-based Omni developed its OmniBotics system as an imageless total knee replacement solution which combines a robotic cutting guide with a robotic tool to measure ligament function. The system allows surgeons to tailor the implant position to each […]
Tasso lands $6m to launch home blood-collection device
Blood-collection startup Tasso said it has completed a $6.1 million financing round led by Vertical Venture Partners (VVP), with participation from Techstars and Cedars-Sinai. The funding will help Tasso scale its first product, Tasso OnDemand, which enables self-collection of blood samples, and to add personnel to support commercial growth. Tasso OnDemand allows people to collect blood at home […]
GE Healthcare adds Adventist Health to hospital collaborator list
GE Healthcare has signed an agreement to provide advanced analytics and reduce process variation for the 21-hospital Adventist Health system in California, Oregon and Hawaii, the health system announced. The five-year collaboration is designed to maximize the capacity of Adventist’s clinical assets and improve patient care delivery. Adventist said it expects the collaboration to spur […]
Saranas’ Early Bird catches nod from FDA
Saranas said today that FDA has granted its Early Bird endovascular bleed monitoring system de novo designation. The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, such as TAVR, large-bore hemodynamic support device placement, or […]
Patient deaths prompt renewed warning to heed LifeVest alert
FDA has issued another update to a previous voluntary recall of Asahi Kasei (TYO:3407) subsidiary Zoll Medical‘s LifeVest 4000 wearable automatic external defibrillators following two patient deaths. In January and July 2018, the agency and the company advised patients to contact Zoll immediately for a replacement if their device displays the message: “Call for Service—Message Code 102.” […]
Sotera Wireless adds tools to patient monitoring system
Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis. Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after […]
FDA slaps Class 1 designation on corneal implant recall
FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation. Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, […]
Cultivate(MD) buys into Embody and its ortho injury implant
Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Embody, a startup that has developed a collagen-based microfiber implant designed for use in Achilles’ and rotator cuff repairs. Embody (Norfolk, Va.) based its Tapestry implant on research on collagen-accelerating recellularization by growing new aligned tissue over surgical repairs. The company previously […]